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- Essai clinique NCT04453605
Phenotyping Individuals With Neo-diagnosed Type 2 Diabetes at Risk for All-cause Mortality
Determining All Cause Morality and Cardiovascular Mortality Risk in Individuals With Neo-diagnosed Type 2 Diabetes
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Patients referring for the first time to the outpatient diabetes clinic in the department of Internal Medicine between January 2008 and December 2015 and matching the inclusion criteria were recruited.
Diagnosis was confirmed on the basis of the Oral Glucose Tolerance Test (OGTT) or HbA1c ≥6.5% plus fasting blood glucose ≥126 mg/dl.
Anthropometric measurements were recorded, arterial pressure and vital parameters were registered, and blood samples were collected for routine analyses. Complete blood count, glucose, HbA1c, Serum Glutamic Oxaloacetic Transaminase (sGOT), Serum Glutamic Pyruvic Transaminase (sGPT), uric acid, were determined by standard techniques. Total and HDL cholesterol and triglycerides were assayed through the automated spectrophotometer, enzymatic colorimetric method, COBAS INTEGRA using commercial kits (Roche Diagnostics). Serum creatinine was measured by Jaffe' method, and estimated glomerular filtration rate (eGFR) was calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Previous major acute CV events, including myocardial infarction, stroke, foot ulcer/gangrene/amputation and coronary, carotid and lower limb revascularisation, were adjudicated based on hospital discharge records.
At the end of the baseline visit, patients were treated according to the good clinical practice recommended by the international guidelines, and followed a six-month or an yearly calendar of follow-up visits, until death or until 31 December 2018. All-cause mortality was assessed by checking the vital status of study participants on 31 December 2018; to this aim, investigators interrogated the Italian Health Card database, which provides updated information on all current Italian residents.
Incident major acute cardiovascular events were registered on the basis of clinical records every year; retinopathy onset was assessed by fundoscopy on a yearly basis.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Pisa, Italie, 56125
- University of Pisa
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- age ≥30 years
- personal history of known T2D lasting not more than six months
- diagnosis confirmed on the basis of the OGTT or HbA1c ≥6.5% plus fasting blood glucose ≥126 mg/dl
Exclusion Criteria:
- longstanding disease duration
- type 1 diabetes
- diabetes secondary to steroid therapy
- active cancer
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Patients with neo-diagnosed type 2 diabetes
Patients referring for the first time to the outpatient diabetes clinic in the department of Internal Medicine between January 2008 and December 2015 and matching the inclusion criteria.
|
patients were treated according to the good clinical practice recommended by the international guidelines, and followed a six-month or an yearly calendar of follow-up visits
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of participants who died during the study
Délai: At 31 December 2018
|
The number of participants who died during the study was assessed by checking the vital status of study participants on 31 December 2018; to this aim, we interrogated the Italian Health Card database, which provides updated information on all current Italian residents.
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At 31 December 2018
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Incidence of cardiovascular disease
Délai: At 31 December 2018
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Incident major acute cardiovascular events were registered on the basis of clinical records every year
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At 31 December 2018
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Incidence of microvascular complication
Délai: At 31 December 2018
|
Retinopathy onset was assessed by fundoscopy on a yearly basis.
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At 31 December 2018
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change of renal function through study completion (an average of 5 year)
Délai: From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.
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Serum creatinine was measured by Jaffe' method and expressed by mg/dl.
It was used to calculate eGFR according to the CKD-EPI formula.
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From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.
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Change of blood glucose through study completion (an average of 5 year)
Délai: From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.
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Blood glucose was expressed in mg/dl and was determined by standard techniques.
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From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.
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Change of HbA1c through study completion (an average of 5 year)
Délai: From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.
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HbA1c was expressed as percentage or mmol/l and was determined by standard techniques.
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From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Whiting DR, Guariguata L, Weil C, Shaw J. IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res Clin Pract. 2011 Dec;94(3):311-21. doi: 10.1016/j.diabres.2011.10.029. Epub 2011 Nov 12.
- Tancredi M, Rosengren A, Svensson AM, Kosiborod M, Pivodic A, Gudbjornsdottir S, Wedel H, Clements M, Dahlqvist S, Lind M. Excess Mortality among Persons with Type 2 Diabetes. N Engl J Med. 2015 Oct 29;373(18):1720-32. doi: 10.1056/NEJMoa1504347.
- Gregg EW, Zhuo X, Cheng YJ, Albright AL, Narayan KM, Thompson TJ. Trends in lifetime risk and years of life lost due to diabetes in the USA, 1985-2011: a modelling study. Lancet Diabetes Endocrinol. 2014 Nov;2(11):867-74. doi: 10.1016/S2213-8587(14)70161-5. Epub 2014 Aug 12.
- Ghouse J, Isaksen JL, Skov MW, Lind B, Svendsen JH, Kanters JK, Olesen MS, Holst AG, Nielsen JB. Effect of diabetes duration on the relationship between glycaemic control and risk of death in older adults with type 2 diabetes. Diabetes Obes Metab. 2020 Feb;22(2):231-242. doi: 10.1111/dom.13891. Epub 2019 Nov 18.
- Gimeno Orna JA, Blasco Lamarca Y, Campos Gutierrez B, Molinero Herguedas E, Lou Arnal LM. [Morbidity and mortality cardiovascular risk in dependence of type 2 diabetes duration]. Clin Investig Arterioscler. 2014 May-Jun;26(3):122-30. doi: 10.1016/j.arteri.2013.11.010. Epub 2014 Jan 23. Spanish.
- Herrington WG, Alegre-Diaz J, Wade R, Gnatiuc L, Ramirez-Reyes R, Hill M, Solano-Sanchez M, Baigent C, Lewington S, Collins R, Tapia-Conyer R, Peto R, Kuri-Morales P, Emberson JR. Effect of diabetes duration and glycaemic control on 14-year cause-specific mortality in Mexican adults: a blood-based prospective cohort study. Lancet Diabetes Endocrinol. 2018 Jun;6(6):455-463. doi: 10.1016/S2213-8587(18)30050-0. Epub 2018 Mar 19.
- Huo L, Magliano DJ, Ranciere F, Harding JL, Nanayakkara N, Shaw JE, Carstensen B. Impact of age at diagnosis and duration of type 2 diabetes on mortality in Australia 1997-2011. Diabetologia. 2018 May;61(5):1055-1063. doi: 10.1007/s00125-018-4544-z. Epub 2018 Feb 22.
- Huang Y, Cai X, Mai W, Li M, Hu Y. Association between prediabetes and risk of cardiovascular disease and all cause mortality: systematic review and meta-analysis. BMJ. 2016 Nov 23;355:i5953. doi: 10.1136/bmj.i5953.
- Smith NL, Barzilay JI, Kronmal R, Lumley T, Enquobahrie D, Psaty BM. New-onset diabetes and risk of all-cause and cardiovascular mortality: the Cardiovascular Health Study. Diabetes Care. 2006 Sep;29(9):2012-7. doi: 10.2337/dc06-0574.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AS0006
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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